Distractors having attachable paddles, impaction devices, and methods for use in total ankle replacement

ABSTRACT

A distractor system for use in a joint between two bone surfaces of an anatomical structure includes, for example, distractor and at least one detachable tool comprising a body having a proximal portion and a distal portion, said proximal portion being releasably attachable to at least one of a first end of the distractor and/or a second end of the distractor. The distal portion of the detachable tool being operably positionable in the joint between the two bone surfaces of the anatomical structure. The detachable tools may include a detachable paddle.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Patent ApplicationNo. PCT/US2019/066398, filed on Dec. 13, 2019, entitled “DistractorsHaving Attachable Paddles, Impaction Devices, And Methods For Use InTotal Ankle Replacement” (Attorney Docket No. 3645.159AWO), whichinternational patent application claims priority benefit under 35 U.S.C.§ 119(e) to U.S. Provisional Patent Application No. 62/898,854, filedSep. 11, 2019, entitled “Distractors Having Attachable Paddles,Impaction Devices, And Methods For Use In Total Ankle Replacement,”(Attorney Docket No. 3645.159P1), claims priority benefit under 35U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62/779,436,filed Dec. 13, 2018, entitled “Joint Replacement Systems And Methods OfUse And Assembly” (Attorney Docket No. 3645.138P), and claims prioritybenefit under 35 U.S.C. § 119(e) to U.S. Provisional Patent ApplicationNo. 62/779,092, filed Dec. 13, 2018, entitled “Instruments, Guides andRelated Methods for Total Ankle Replacement” (Attorney Docket No.3645.144P), which applications are hereby incorporated herein byreference in their entireties.

TECHNICAL FIELD

The present disclosure relates generally to general surgery, podiatric,and orthopaedic instruments used for correcting bone deformities. Morespecifically, but not exclusively, the present disclosure relates topatient specific instruments, systems, and methods for maintaining,correcting and/or resurfacing joint surfaces such as for use in totalankle replacement.

BACKGROUND

Total ankle replacement (TAR), or ankle arthroplasty, is a surgicalprocedure to replace deformed and/or damaged articular surfaces of thehuman ankle joint with a prosthetic joint while preserving thefunctional range of motion (ROM) of the ankle joint.

Typical TAR prosthesis include a tibial implant component, a talusimplant component, and a bearing or insert component positioned betweenthe tibial and talus prosthesis components.

Achieving a stable replacement ankle joint that provides for fullarticulation/motion (e.g., achieving a range of motion of a typical“healthy” ankle joint) generally requires proper sizing andpositioning/orientating/aligning of the tibial implant component withrespect to the distal end of a tibia, of the talus implant componentwith respect to the proximal end of a talus, and of the insert or spacertherebetween.

For example, proper sizing and position/orientation of the tibialprosthesis, the talus prosthesis and the tibial insert of a TARprosthesis with respect to an ankle joint of a particular patient canprevent overstuffing or understuffing of the replacement ankle joint(and thereby provide full articulation/motion) and can ensure propercoverage of the tibial prosthesis on the tibia and the talus prosthesison the talus. As another example, the position/orientation/alignment ofthe tibial prosthesis, the talus prosthesis and the insert or spacerwith respect to the mechanical axis of an ankle joint of a particularpatient (e.g., the mechanical axis of the tibia) can ensure themechanical forces of the replacement ankle joint are properlydistributed and full and properly-oriented range of motion is achieved.

SUMMARY

Shortcomings of the prior art are overcome and additional advantages areprovided through the provision in one embodiment of a distractor systemfor use in a joint between bone surfaces of an anatomical structure. Thedistractor system includes, for example, a first pivotable member havinga first user engageable arm and an opposite first end, and a secondpivotable member having a second user engageable arm and an oppositeend. The first pivotable member is pivotably connected to the secondpivotable member between the user engageable arms and the ends. A firstconnecting member has a first end and a second end, and the first end ispivotally connected to the first end of the first pivotable member. Asecond connecting member has a first end and a second end, and the firstend is pivotally connected to the second end of the second pivotablemember. A biasing member is operable for biasing the first arm away fromthe second arm so that the second end of the first connecting member isbiased towards the second end of the second member. At least onedetachable tool includes a body having a proximal portion and a distalportion. The proximal portion is releasably attachable to at least oneof the second end of the first connection member and/or the second endof the second connecting member. The distal portion is operablypositionable in the joint between the bone surfaces of the anatomicalstructure.

In another embodiment, the present disclosure provides a surgicalmethod, which incudes for example, providing the above distractor,attaching a pair of tools to the distractor, and inserting the pair oftools in the joint between the two bone surfaces of the anatomicalstructure.

In another embodiment, the present disclosure provides a surgical methodfor use between a first bone surface and a second bone surface of ananatomical structure, which includes, for example, selecting a firstdetachable tool and a second detachable tool from a plurality ofdifferent detachable tools, attaching the first detachable tool to afirst connector of a distractor, attaching the second detachable tool toa second connector of the distractor, using the distracter to insert thefirst detachable tool and the second detachable tool between the firstbone surface and the second bone surface of the anatomical structure.

In another embodiment, the surgical method may further include providingan implant trialing and cutting guide, inserting the implant trialingand cutting guide between a resected portion of the first bone and thefirst paddle, and wherein the using includes using the distractor andthe first detachable tool to seat the implant trialing and cutting guidein the resected portion of the first bone. The surgical method mayfurther include selecting a third detachable tool having at least onecutting and/or punch pin, removing the first detachable tool from thefirst connector of the distractor, attaching the third detachable toolto the first connector of the distractor, passing the at least onecutting and/or punch pin through the implant trialing and cutting guideseated in the resected portion of the first bone, and using thedistractor to force the at least one cutting and/or punch pin into theresected portion of the first bone. Still other embodiments of thesurgical method may further include removing the third detachable toolfrom the first connector of the distractor, removing the implanttrialing and cutting guide from the resected portion of the first bone,attaching the fourth detachable tool to the first connector of thedistractor, inserting an implant component in the resected portion ofthe first bone and the positioning an impaction protector between theimplant component and the fourth detachable tool, and using thedistractor to seat the implant component in the resected portion of thefirst bone.

In another embodiment, the present disclosure provides a detachable toolto a first movable end or a second movable end of a distractor for usebetween bone surfaces of an anatomical structure, which includes, forexample, a body having a proximal portion and a distal portion, theproximal portion configured for releasably attaching to the firstmovable end of the distractor, and the distal portion includes a planarmember having a first planar surface and a second planar surface.

In another embodiment, the present disclosure provides a detachableresection guide tool releasably attachable to a first movable end and/ora second movable end of a distractor for use between bone surfaces of ananatomical structure. The detachable resection guide tool may include,for example, a body having a proximal portion and a distal portion. Theproximal portion is configured for releasably attaching to the firstmovable end of the distractor, and the distal portion comprising aresection guide.

In another embodiment, the present disclosure provides a detachableresection guide tool releasably attachable to a first movable end of adistractor for use between bone surfaces of an anatomical structure. Thedetachable resection guide tool may include, for example, a body havinga proximal portion and a distal portion. The proximal portion isconfigured for releasably attaching to the first movable end of thedistractor, and the distal portion comprising an implant trialing andcutting guide.

In another embodiment, the present disclosure provides an implantimpaction system for use in installing an implant, which includes, forexample, a body having a U-shaped configuration defining a centralhandle portion, a proximal impact portion, and a distal portion. Adetachable projecting member having a proximal portion and a distalportion, the proximal portion releasably attachable to the distalportion of the body. An impaction protector is supportable on the distalportion of the projecting member. The impaction protector ispositionable between the implant and the projecting member duringimplanting of the implant.

Additional features are realized through the techniques of the presentdisclosure. Other embodiments and aspects of the present disclosure aredescribed in detail herein and are considered a part of the claimeddisclosure.

These and other objects, features and advantages of this disclosure willbecome apparent from the following detailed description of the variousaspects of the disclosure taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter which is regarded as the disclosure is particularlypointed out and distinctly claimed in the concluding portion of thespecification. The disclosure, however, may best be understood byreference to the following detailed description of various embodimentsand the accompanying drawings in which:

FIG. 1 is a perspective view of a distractor system having a distractorand detachable paddles, according to an embodiment of the presentdisclosure;

FIG. 2 is a perspective view of the distractor of FIG. 1, according toan embodiment of the present disclosure;

FIG. 3 is a front elevational of view the distractor of FIG. 1,according to an embodiment of the present disclosure;

FIG. 4 is a rear elevational view of the distractor of FIG. 1, accordingto an embodiment of the present disclosure;

FIG. 5 is a top view of the distractor of FIG. 1, according to anembodiment of the present disclosure;

FIG. 6 is a bottom view of the distractor of FIG. 1, according to anembodiment of the present disclosure;

FIG. 7 is right side elevational view of the distractor of FIG. 1,according to an embodiment of the present disclosure;

FIG. 8 is left side elevational view of the distractor of FIG. 1,according to an embodiment of the present disclosure;

FIG. 9 is an enlarged side elevational view of the scissors mechanism ofthe distractor of FIG. 1, according to an embodiment of the presentdisclosure;

FIG. 10 is an enlarged perspective view of the first and secondconnecting members and scissors mechanism of the distractor of FIG. 1,according to an embodiment of the present disclosure;

FIG. 11 is a top perspective view of one of the detachable paddles ofthe distractor system of FIG. 1, according to an embodiment of thepresent disclosure;

FIG. 12 is a bottom perspective view of the detachable paddle of FIG.11, according to an embodiment of the present disclosure;

FIG. 13 is a front elevational view of the detachable paddle of FIG. 11,according to an embodiment of the present disclosure;

FIG. 14 is a rear elevational view of the detachable paddle of FIG. 11,according to an embodiment of the present disclosure;

FIG. 15 is a top view of the detachable paddle of FIG. 11, according toan embodiment of the present disclosure;

FIG. 16 is a bottom view of the detachable paddle of FIG. 11, accordingto an embodiment of the present disclosure;

FIG. 17 is left side elevational view of the detachable paddle of FIG.11, according to an embodiment of the present disclosure;

FIG. 18 is right side elevational view of the detachable paddle of FIG.11, according to an embodiment of the present disclosure;

FIG. 19 is perspective view of a tibial implant trialing and cuttingguide and the distractor assembly of FIG. 1, according to an embodimentof the present disclosure;

FIG. 20 is an enlarged top perspective view of the tibial implanttrialing and cutting guide of FIG. 19, according to an embodiment of thepresent disclosure;

FIG. 21 is a bottom perspective view of the tibial implant trialing andcutting guide of FIG. 20, according to an embodiment of the presentdisclosure;

FIG. 22 is a bottom perspective view of the tibial implant trialing andcutting guide of FIG. 20 and the detachable paddle, according to anembodiment of the present disclosure;

FIG. 23 is a front elevational view of the tibial implant trialing andcutting guide of FIG. 20 installed in a resected bone, according to anembodiment of the present disclosure;

FIG. 24 is a perspective view of an tibial implant trialing and cuttingguide, the distractor assembly with a detachable cutting and/or punchtool, according to an embodiment of the present disclosure;

FIG. 25 is an enlarged top perspective view of the detachable cuttingand/or punch tool of FIG. 24, according to an embodiment of the presentdisclosure;

FIG. 26 is a bottom perspective view of the detachable cutting and/orpunch tool of FIG. 25, according to an embodiment of the presentdisclosure;

FIG. 27 is a front elevational view of the detachable cutting and/orpunch tool of FIG. 25, according to an embodiment of the presentdisclosure;

FIG. 28 is a rear elevational view of the detachable cutting and/orpunch tool of FIG. 25, according to an embodiment of the presentdisclosure;

FIG. 29 is a top view of the detachable cutting and/or punch tool ofFIG. 25, according to an embodiment of the present disclosure;

FIG. 30 is a bottom view of the detachable cutting and/or punch tool ofFIG. 25, according to an embodiment of the present disclosure;

FIG. 31 is left side elevational view of the detachable cutting and/orpunch tool of FIG. 25, according to an embodiment of the presentdisclosure;

FIG. 32 is right side elevational view of the detachable cutting and/orpunch tool of FIG. 25, according to an embodiment of the presentdisclosure;

FIG. 33 is a perspective view of a detachable tibial implant trialingand cutting guide, distractor assembly with detachable paddles, and adetachable talar implant trialing and cutting guide, according to anembodiment of the present disclosure;

FIG. 34 is an enlarged, top perspective view of the detachable tibialimplant trialing and cutting guide, the detachable paddles, and thedetachable talar implant trialing and cutting guide of FIG. 33,according to an embodiment of the present disclosure;

FIG. 35 is an enlarged, bottom perspective view of the detachable tibialimplant trialing and cutting guide, the detachable paddles, and thedetachable talar implant trialing and cutting guide of FIG. 33,according to an embodiment of the present disclosure;

FIG. 36 is an enlarged, top perspective view of the detachable talarpaddle of FIG. 33, according to an embodiment of the present disclosure;

FIG. 37 is a bottom perspective view of the detachable talar paddle ofFIG. 36, according to an embodiment of the present disclosure;

FIG. 38 is an enlarged, top perspective view of the talar implanttrialing and cutting guide of FIG. 33, according to an embodiment of thepresent disclosure;

FIG. 39 is a bottom perspective view of the talar implant trialing andcutting guide of FIG. 38, according to an embodiment of the presentdisclosure;

FIG. 40 is a perspective view of a tibial implant component and thedistractor assembly with the detachable paddles and an impactionprotection, according to an embodiment of the present disclosure;

FIG. 41 is an enlarged top perspective view of the impaction protectorof FIG. 40, according to an embodiment of the present disclosure;

FIG. 42 is a bottom perspective view of the impaction protector of FIG.41, according to an embodiment of the present disclosure;

FIG. 43 is a front elevational view of the impaction protector of FIG.41, according to an embodiment of the present disclosure;

FIG. 44 is a rear elevational view of the impaction protector of FIG.41, according to an embodiment of the present disclosure;

FIG. 45 is left side elevational view of the impaction protector of FIG.41, according to an embodiment of the present disclosure;

FIG. 46 is right side elevational view of the impaction protector ofFIG. 41, according to an embodiment of the present disclosure;

FIG. 47 is a top view of the impaction protector of FIG. 41, accordingto an embodiment of the present disclosure;

FIG. 48 is a bottom view of the impaction protector of FIG. 41,according to an embodiment of the present disclosure;

FIG. 49 is an enlarged top perspective view of the detachable tibialpaddle of FIG. 40, according to an embodiment of the present disclosure;

FIG. 50 is a bottom perspective view of the detachable tibial paddle ofFIG. 49, according to an embodiment of the present disclosure;

FIG. 51 is a flowchart of a surgical method, according to an embodimentof the present disclosure;

FIG. 52 is a flowchart of a surgical method, according to an embodimentof the present disclosure;

FIG. 53 is a perspective view of an impaction system, tibial implantcomponent, and a detachable impaction projector, according to anembodiment of the present disclosure;

FIG. 54 is a perspective view of the impaction system of FIG. 53,according to an embodiment of the present disclosure;

FIG. 55 is an exploded perspective view of the impaction system of FIG.54, according to an embodiment of the present disclosure;

FIG. 56 is an exploded front elevational view of the impaction system ofFIG. 54, according to an embodiment of the present disclosure;

FIG. 57 is an exploded rear elevational view of the impaction system ofFIG. 54, according to an embodiment of the present disclosure;

FIG. 58 is an exploded right side elevational view of the impactionsystem of FIG. 54, according to an embodiment of the present disclosure;

FIG. 59 is an exploded left side elevational view of the impactionsystem of FIG. 54, according to an embodiment of the present disclosure;

FIG. 60 is a top view of the impaction system of FIG. 54, according toan embodiment of the present disclosure;

FIG. 61 is a bottom view of the impaction system of FIG. 54, accordingto an embodiment of the present disclosure;

FIG. 62 is a top perspective view of a detachable paddle, according toan embodiment of the present disclosure;

FIG. 63 is a bottom perspective view of the detachable paddle of FIG.62, according to an embodiment of the present disclosure;

FIG. 64 is a side elevational view of the detachable paddle of FIG. 62,according to an embodiment of the present disclosure;

FIG. 65 is a side elevational view of the detachable paddle of FIG. 62,according to an embodiment of the present disclosure;

FIG. 66 is a top view of the detachable paddle of FIG. 62, according toan embodiment of the present disclosure;

FIG. 67 is a bottom view of the detachable paddle of FIG. 62, accordingto an embodiment of the present disclosure;

FIG. 68 is front side elevational view of the detachable paddle of FIG.62, according to an embodiment of the present disclosure;

FIG. 69 is back side elevational view of the detachable paddle of FIG.62, according to an embodiment of the present disclosure;

FIG. 70 is a perspective view of a distractor, according to anembodiment of the present disclosure;

FIG. 71 is an exploded, bottom perspective view of the detachable paddleof FIG. 62 and a tibial implant trialing and cutting guide, according toan embodiment of the present disclosure;

FIG. 72 is a bottom perspective view of the detachable paddle of FIG. 62nested in the tibial implant trialing and cutting guide, according to anembodiment of the present disclosure;

FIG. 73 is a side elevational view of an assembly of the detachablepaddle nested in the tibial implant trialing and cutting guide of FIG.62 along with a distractor and detachable talus paddle, according to anembodiment of the present disclosure;

FIG. 74 is an enlarged cross-sectional view of the assembly of FIG. 73,according to an embodiment of the present disclosure;

FIG. 75 is a top view of a detachable paddle, according to an embodimentof the present disclosure;

FIG. 76 is a top view of a detachable paddle, according to an embodimentof the present disclosure;

FIG. 77 is a perspective view of an assembly of the distractor of FIG.70, a detachable paddle, and a detachable talus paddle, according to anembodiment of the present disclosure;

FIG. 78 are top views of a plurality of detachable talus paddles,according to embodiments of the present disclosure;

FIG. 79 is a side elevational view of an assembly of a tibial implanttrialing and cutting guide, a detachable paddle, and a detachable taluspaddle, according to an embodiment of the present disclosure;

FIG. 80 is a top perspective view of a detachable cutting and/or punchtool, according to an embodiment of the present disclosure;

FIG. 81 is a bottom perspective view of the detachable cutting and/orpunch tool of FIG. 80, according to an embodiment of the presentdisclosure;

FIG. 82 is a side elevational view of an assembly of the detachablecutting and/or punch tool of FIG. 80 along with a distractor, a tibialtrial and cutting guide, and a detachable talus paddle, according to anembodiment of the present disclosure;

FIG. 83 is an enlarged, partial perspective view of the detachablecutting and/or punch tool of FIG. 80, according to an embodiment of thepresent disclosure;

FIG. 84 is a top perspective view of an impaction protector, accordingto an embodiment of the present disclosure;

FIG. 85 is a bottom perspective view of the impaction protector of FIG.84, according to an embodiment of the present disclosure;

FIG. 86 is a top perspective view of a detachable tibial implantationpaddle, according to an embodiment of the present disclosure;

FIG. 87 is a bottom perspective view of the detachable tibialimplantation paddle of FIG. 86, according to an embodiment of thepresent disclosure;

FIG. 88 is a side elevational view of an assembly of the detachabletibial implantation paddle of FIG. 86 along with a distractor, a tibialimplant component, and an impaction protector, according to anembodiment of the present disclosure;

FIG. 89 is a partial top view of the assembly of FIG. 88, according toan embodiment of the present disclosure;

FIG. 90 is a partial bottom view of the assembly of FIG. 88, accordingto an embodiment of the present disclosure;

FIG. 91 is a perspective view of an impaction system, according to anembodiment of the present disclosure;

FIG. 92 is an enlarged perspective view of the detachable projectingmember of the impaction system of FIG. 91, according to an embodiment ofthe present disclosure;

FIG. 93 is an enlarged, exploded perspective view of the detachableprojecting member of the impaction system of FIG. 91 along with adetachable tibial implantation paddle, a tibial impaction protector, anda tibial implant component, according to an embodiment of the presentdisclosure;

FIG. 94 is a perspective view of a detachable projecting member,according to an embodiment of the present disclosure;

FIG. 95 is a bottom view of the detachable projecting member of FIG. 94nested in a tibial impaction protector, according to an embodiment ofthe present disclosure;

FIG. 96 is a top perspective view of a detachable talar implant trialingand cutting guide, according to an embodiment of the present disclosure;

FIG. 97 is a bottom perspective view of the detachable talar implanttrialing and cutting guide of FIG. 96, according to an embodiment of thepresent disclosure;

FIG. 98 is a side elevational view of an assembly of the talar implanttrialing and cutting guide of FIG. 96, a distractor, a detachablepaddle, and a tibial trialing implant, according to an embodiment of thepresent disclosure;

FIG. 99 is a top perspective view of a detachable talar implant trialingand cutting guide, according to an embodiment of the present disclosure;

FIG. 100 is a bottom perspective view of the detachable talar implanttrialing and cutting guide of FIG. 99, according to an embodiment of thepresent disclosure;

FIG. 101 is a side elevational view of an assembly of the detachabletalar implant trialing and cutting guide of FIG. 99, a distractor, adetachable paddle, and a tibial trialing implant, according to anembodiment of the present disclosure;

FIG. 102 is a perspective view of the implant impaction system theprojecting member employed with the distractor for implanting a tibialimplant component, according to an embodiment of the present disclosure;

FIG. 103 is a perspective view of a detachable talus trialing implantand cut guide and a 2-holed resection insert, according to an embodimentof the present disclosure; and

FIG. 104 is a perspective view of a detachable talus trialing implantand cut guide and a single slotted resection insert, according to anembodiment of the present disclosure.

DETAILED DESCRIPTION

The present disclosure is directed to instruments, guides, systems andrelated methods for, for example, total ankle replacement prostheses.The instruments, guides, systems and related methods may facilitatepreparation of a tibia and/or talus of a patient for implantation of atotal ankle prosthesis therein. The instruments, guides, systems andrelated methods may also facilitate selection of a particular size of atibial trialing component, tibial implant component, a talus trialingcomponent, a talus implant component, and/or a tibial insert of thetotal ankle prosthesis that suits the patient.

In this detailed description and the following claims, the wordsproximal, distal, anterior or plantar, posterior or dorsal, medial,lateral, superior and inferior are defined by their standard usage forindicating a particular part or portion of a bone, joint (or any otheranatomical structure) or implant according to the relative dispositionof the natural bone, joint (or any other anatomical structure) ordirectional terms of reference. For example, “proximal” means theportion of a device or instrument nearest the torso, while “distal”indicates the portion of the device or instrument farthest from thetorso. As for directional terms, “anterior” is a direction towards thefront side of the body, “posterior” means a direction towards the backside of the body, “medial” means towards the midline of the body,“lateral” is a direction towards the sides or away from the midline ofthe body, “superior” means a direction above and “inferior” means adirection below another object or structure. Further, specifically inregards to the foot and/or ankle, the term “dorsal” refers to the top ofthe foot and the term “plantar” refers the bottom of the foot.

Similarly, positions or directions may be used herein with reference toanatomical structures or surfaces. For example, as the currentinstruments, guides, systems and related methods (and componentsthereof) are described herein with reference to use with the bones ofthe ankle, the bones of the foot, ankle and lower leg may be used todescribe the surfaces, positions, directions or orientations of theinstruments, guides, systems and related methods (and componentsthereof). Further, the instruments, guides, systems and related methods,and the aspects, components, features and the like thereof, disclosedherein may be described with respect to one side of the body (e.g., theleft or right ankle) for brevity purposes. However, as the human body isrelatively symmetrical or mirrored about a line of symmetry (midline),it is hereby expressly contemplated that the instruments, guides,systems and related methods, and the aspects, components, features andthe like thereof, described and/or illustrated herein may be changed,varied, modified, reconfigured or otherwise altered for use orassociation with another side of the body for a same or similar purposewithout departing from the spirit and scope of the disclosure. Forexample, the instruments, guides, systems and related methods, and theaspects, components, features and the like thereof, described hereinwith respect to the right ankle of a patient may be mirrored so thatthey likewise function with the left ankle of the patient. Further, theinstruments, guides, systems and related methods, and the aspects,components, features and the like thereof, disclosed herein aredescribed with respect to the ankle for brevity purposes, but it shouldbe understood that the instruments, guides, systems and related methods(and components thereof) may be used with other joints of a human body(or other mammalian body) having similar structures.

FIG. 1 illustrates a distractor system 100, according to an embodimentof the present disclosure. The distractor system 100 is operable for usein separating bone surfaces of an anatomical structure. In the variousembodiments as descried below, the distractor systems of the presentdisclosure are operable, for example, for separating bones, trialingimplants, and installing implants, such as for use in a total anklereplacement prosthesis. In this illustrated embodiment, the distractorsystem 100 may include a distractor 200 and a plurality detachablepaddles 300.

As shown in FIGS. 2-8, the distractor 200 may include a user operableportion or pivotable portion 202 and a connecting portion 204. As shownin FIG. 2, the pivotable portion 202 may generally include a firstpivotable member 210 and a second pivotable member 220. The firstpivotable member 210 includes a first user engageable arm 212 and anopposite first end 214. The second pivotable member 220 includes asecond user engageable arm 222 and an opposite second end 224. The firstpivotable member 210 is pivotably connected to the second pivotablemember 220. For example, the first pivotable member 210 may be pivotallyconnected via a pin 215 disposed between the user engageable arms 212and 222 and the end ends 214 and 224.

The connecting portion 204 may include a first connecting member 230 anda second connecting member 240. In this illustrated embodiment, thefirst connecting member 230 and a second connecting member 240 may beoperably connected via a scissors mechanism 250, which maintains thefirst connecting member parallel to the second connecting member 240 asthe first connecting member 230 and a second connecting member 240 aremoved towards and away from each other.

The first connecting member 230 may be an elongated member having afirst end 232 and a second end 234. The first end 232 is pivotallyconnected to the first end 214 of the first pivotable member 210 via apin 217. The second connecting member 240 may be an elongated memberhaving a first end 242 and a second end 244. The first end 242 ispivotally connected to the second end 224 of the second pivotable member220 via pin 219.

With reference to FIG. 9, the scissors mechanism 250 may include a pairof crisscrossing members 251 and 255. The first crisscrossing member 251includes a first end 252 and a second end 253. The second crisscrossingmember 255 includes a first end 256 and a second end 257. The centers ofthe crisscrossing member 251 and 255 are pivotally attached with a pin259.

As shown in FIG. 10, the connecting members 230 and 240 of theconnecting portion 204 may be generally hollow for receiving thescissors mechanism 250 therein. The end 252 (FIG. 9) of the firstcrisscrossing member 251 of the scissors mechanism 250 is operablypivotally attachable to the first connecting member 230 via a pin 261.The end 256 (FIG. 9) of the second crisscrossing member 255 of thescissors mechanism 250 is operably pivotally attachable to the secondconnecting member 240 via a pin 263. The end 257 (FIG. 9) of the firstcrisscrossing member 251 of the scissors mechanism 250 is operablyslidably pivotally attachable to the first connecting member 230 via apin 265. The end 253 of the second crisscrossing member 253 of thescissors mechanism is operably slidably pivotally attachable to thesecond connecting member 240 via a pin 267. As shown in FIG. 10, the pin265 may be constrained to travel within a track 236 in the firstconnecting member 230, and the pin 267 may be constrained to travelwithin a track 246 in the second connecting member 240. Thus, movementof the end 214 and 224 (FIG. 2) of arms 210 and 220 (FIG. 2),respectively, towards and away from each other causes ends 232 and 242or connecting members 230 and 240 to move towards and away from eachother.

With reference again to FIGS. 2-4, a biasing member 270 may include afirst spring member 272 and a second spring member 274. An end 271 ofspring member 272 may be attached to the end 212 of the arm 210 and anend 275 of spring member 274 may be attached to the end 222 of the arm220. Second ends 273 and 276 may be operably connected to place thespring member 270 in compression so that the ends 212 of the arms 222,respectively, are biased away from each other. Such a configurationresults in the ends 214 and 224 being biased toward each other. Thedistractor 200 may include a ratchet 280 having a first end 282pivotally attached to the second arm 220 and teeth 284 selectivelyreleasably attachable with the first arm 210 to maintain the ends 214and 224, and thus the detachable paddles 300 (FIG. 1) in a fixedrelationship to each other. For example, the ratchet 280 may allowlocking the distractor 200 in position.

With reference again to FIG. 10, the second end 234 of the firstconnector 230 may include a first post 293, and the second end 244 ofthe second connector 240 may include a second post 294. The first post293 may define a first axis A1, the second post 294 may define a secondaxis A2. The first axis and the second axis may be disposed andmaintained parallel to each other. The first post 293 may have a squarecross section and the second post 294 may have a square cross section.In some embodiments, the first post 293 may include alaterally-extending projection 295 and the second post 294 may include alaterally-extending projection 297. As described below, the detachablepaddles 300 (FIG. 1) may be configured to be connected, orientated, andsecured on to the posts of the connecting members.

FIGS. 11-18 illustrate the detachable paddle 300, according to anembodiment of the present disclosure. For example, a pair of thedetachable paddles 300 may be employed as shown in FIG. 1. As describedbelow, a surgeon may be provided with a plurality of differently sizedand shaped detachable paddles, which detachable paddles may be selectedby the surgeon depending the operation to be performed in using thedistractor.

In this illustrated embodiment, for example, the detachable paddle 300may include a body 310 having a proximal portion 320 and a distalportion 340. With reference to FIGS. 11 and 12, the proximal portion 320may be configured for releasably attaching to the first post 293 (FIG.10) and/or the second post 294 (FIG. 10) of the distractor 100 (FIG. 1).The distal portion 340 may include a generally planar member having afirst or top planar surface 342 (FIG. 11) and a second or bottom planarsurface 344 (FIG. 12).

The proximal portion 320 of the detachable paddle 300 may include arecess 322, which is supportable on the first post 293 (FIG. 10) and thesecond post 294 (FIG. 10). The proximal portion 320 may also include acutout 324 for receiving the laterally-extending projections 295 or 297(FIG. 10). The recess 322 may have a square cross-section.

As shown in FIG. 12, the second planar surface 344 of the detachablepaddle 300 may include a raised land 346 extending from the secondplanar surface 344 and a recess 348 extending into the second planarsurface 344. With reference to FIGS. 11 and 13, the proximal portion 322of the detachable paddle 300 may define a longitudinal axis L1 and theplanar member 340 of the detachable paddle 300 may define a longitudinalaxis L2. The longitudinal axis L2 of the planar member 340 may be offsetfrom the longitudinal axis L1 of the proximal portion 320.

With reference again to FIG. 12, the raised land 346 may be an elongatedraised land that is disposed on one side of the longitudinal axis L1 andthe longitude axis L2 of the body 310 and the recess 348 may be anelongated recess disposed on an opposite side of the longitudinal axesL1 and L2 of the body 310. In other embodiments, the elongated raisedland 346 may be angled away from the elongated recess 348. In someembodiments, the raised land and recess may be disposed so that a pairof detachable paddles 300 may be positioned with second planar surfaces344 abutting and aligned with each other and the land of one detachablepaddle being received in the recess of the other detachable paddle, andthe recess of one detachable paddle being received around the land ofthe other detachable paddle. The second planar surface of the detachablepaddle may further include a second recess 349 such as a countersunkhole.

With reference to FIG. 19, the distractor 200 and a pair of thedetachable paddles 300 along with a tibial trial component 400 may beoperably used by a surgeon to facilitate the selection of a properlysized tibial trialing component for use in a total ankle replacement(TAR) procedure based on the size/configuration of the ankle of aparticular patient. For example, the tibial trialing component 400 maycorrespond, in at least one aspect, to a tibial implant component of theTAR prosthesis.

As shown in FIGS. 20 and 21, the tibial trialing component 400 mayinclude a base portion 420 and an arm or wing portion 440. Theproximal-distal thickness, the medial-lateral width, and/or theanterior-posterior size/dimension, shape and/or orientation of the baseportion 420 of the tibial trialing component 400 may correspond (e.g.,match or closely approximate) to that of the tibial implant component ofthe TAR prosthesis. The base portion 420 includes a proximal boneengagement surface or side 422 configured to engage/abut the distaltibia (potentially resected) of a patient. In some embodiments, theproximal bone engagement surface 422 of the base portion 420 is convex(e.g., arcuately convex) along the medial-lateral direction. In otherembodiments (not shown), the proximal bone engagement surface 422 of thebase portion 420 may be flat/planar along the medial-lateral direction.

The base portion 420 may include at least one through-hole or aperture425 that extends through the base portion 420 from the proximal boneengagement surface 422 to a distal insert engagement surface or side 424(FIG. 21). In some embodiments, the base portion 420 includes aplurality of through-holes 425 such as a pair of through holes. The atleast one through-hole 425 is configured as a guide hole for a cuttinginstrument (e.g., as described below a detachable cutting and/or punchtool having cutting or punch pins, or a sharp tipped trocar, drill,etc.) to remove portions of the resected distal tibia to accommodate atleast one peg of a corresponding tibial implant component therein. Theillustrative embodiment, as shown in FIGS. 20 and 21, includes twothrough holes 425 having a medial through-hole 425 and a lateralthrough-hole 425. An adjustment screw 442 threadably extends through armor wing portion 440 along the anterior-posterior direction. Theanterior-posterior position/location of the adjustment screw 442relative to the arm portion 440 may be adjusted with the posterior tipof the adjustment screw 442 contacting the anterior face of the tibia 10(FIG. 19) proximal to the resected portion thereof (e.g., the anteriorcrown of the tibia 10).

The distal side 424 (FIG. 21) of the base portion 420 includes a distalrecessed portion 430. The recessed portion 430 of the distal side 424engages with the detachable paddle 300, for example, as shown in FIG.22. With reference again to FIG. 21, the sides of the recessed portion430 may include an undercut or otherwise be angled toward (or away) theperiphery of the base portion 420 as they extend proximally to a planarproximal end surface to form a sliding dovetail socket or female portionfor receiving a corresponding portion of a trial insert (not shown).

With reference again to FIG. 19, the distractor system 100 withdetachable flat paddles 300 is operable to seat tibial trialingcomponent 400. Once the tibial trialing component 400 is seated, forexample as shown in FIG. 23 (the distractor and the detachable paddlesremoved for clarity), pins (not shown) may be operably installed in thearm or wing portion 440 and attached to the patient's tibia 10, tosecure the tibial trialing component 400 in place. The tibia trialingcomponent 400 may be the same or similar to the tibia trialingcomponents described in greater detail in U.S. provisional applicationNo. 62/779,092, entitled “Instruments, Guides And Related Methods ForTotal Ankle Replacement” (Attorney Docket No. 3645.144P), andInternational PCT Patent Application, filed Dec. 13, 2019, entitled“Instruments, Guides And Related Methods For Total Ankle Replacement”(Attorney Docket No. 3645.144AWO), which are hereby incorporated byreference in their entirety herein.

With reference to FIG. 24, the distractor 100 and the detachable paddle300 and a detachable peg punch paddle 500 may be employed forpreparation of the resected tibia for the tibial implant component pins.For example, as described below, the detachable peg punch paddle 500 mayinclude a punch pins 502 extendable in the cutting through-holes 425(FIG. 20) of the tibial trialing component 400.

FIGS. 25-32 illustrate the detachable peg punch paddle 500, according toan embodiment of the present disclosure. In this illustrated embodiment,the detachable peg punch paddle 500 is essentially the same as paddle300 (FIGS. 11 and 12) with the exception of the addition of the punchpins 502.

With reference to FIGS. 25 and 26, the detachable peg punch paddle 500may include a proximal portion 520 that operably releasably attaches tothe first post 293 (FIG. 10) of first connector member 230 (FIG. 10) ofthe distractor 100 (FIG. 24). A distal portion 540 of the detachable pegpunch paddle 500 may include a planar member having a first planarsurface 542 and a second planar surface 544. Arms 545 may extendoutwardly from the distal edge of the planar member and support thepunch pins 502. For example, cutting and/or punch pins 502 may define alongitudinal axis L3 that are disposed normal or perpendicular to alongitudinal axis of the proximal portion and a longitudinal axis of thedistal portion 540

FIG. 33 illustrates the distractor 100 operably connected to a stackedassembly of the tibial trialing component 400, the detachable paddle300, a detachable paddle 600, and a talar trialing and cut guide 700,according to an embodiment of the present disclosure. FIGS. 34 and 35further illustrate the stack of the tibial trialing component 400, thedetachable paddle 300, the detachable paddle 600, and the talar trialingand cut guide 700.

The illustrated configuration, as shown in FIG. 33, allows distractionto fully seat the talar trialing component onto the dorsal cut of thetalus. In addition, the illustrated configuration allows coupling andneutralizing the talar trial component relative to the tibial trial.

In this illustrated configuration as shown in FIG. 33, the talartrialing and cut guide 700 may correspond, in at least one aspect, to atalar implant component (not shown) of a TAR prosthesis (not shown).Based on the trialing of the tibial trialing component 400, and thetalar trialing and cut guide 700, corresponding tibial implantcomponent, talar implant component, and trialing insert may be selectedbased on the particular patient/ankle that best suits the patient/ankle.The tibial trialing component 400 and the talar trialing and cuttingguide 700 may include a radio radiopaque material such that at least aportion of the components are visible under fluoroscopy or other imagingin situ.

FIGS. 36 and 37 illustrate the detachable talar paddle 600, according toan embodiment of the present disclosure. In this illustrated embodiment,the detachable talar paddle 600 is essentially the same as thedetachable paddle 300 with the exception of the addition of a pin 602for coupling and engaging the talar trialing and cut guide 700. Forexample, the detachable talar paddle 600 may include a first side havingthe pin 602. The pin 602 may be positioned on a raised land 604.

FIGS. 38 and 39 illustrate the talar trialing and cut guide 700 for usewith the detachable talar paddle 600 (FIG. 33) and distractor 100 (FIG.33), according to an embodiment of the present disclosure. The talartrialing and cut guide 700 may include a body 710 having an inferiorsurface 720 (FIG. 39) engageable with a resected surface of the talus ofthe patient (not shown).

As best shown in FIG. 38, a superior surface 740 of the talar trialingcut guide 700 includes a recessed portion 790 having a recessed hole755. The recess portion 790 is sized to receive the land 604 (FIG. 37)of the detachable paddle 600 (FIG. 37), and the recessed hole 750 issized to receive pin 602 (FIG. 37) of detachable paddle 600 (FIG. 37).Other features of the talar trialing and cut guide 700 may include astrut slot 748, a cut slot 750, and pin apertures 752 and 753. Theanterior portion of the strut slot 748 may be utilized by one or morecut guide to resect/chamfer anterior and/or posterior aspects of thetalus. The cut slot 750 can be utilized as a cut guide for the removalof a posterior portion of the talus that extends (and therefore isangled) distally and posteriorly from the resected proximal surface ofthe talus. The pin apertures 752 and 753 may be configured to accept apin, k-wire or other bone fixation member therethrough and into a talus.It will be appreciated that differently sized talar trialing and cutguides 700 may include differing anterior-posterior lengths,medial-lateral widths and/or proximal-distal thicknesses. The talartrialing and cut guide 700 may be the same or similar to the talar trialcomponents described in greater detail in U.S. provisional applicationNo. 62/779,092, entitled “Instruments, Guides And Related Methods ForTotal Ankle Replacement” (Attorney Docket No. 3645.144P), andInternational PCT Patent Application, filed Dec. 13, 2019, entitled“Instruments, Guides And Related Methods For Total Ankle Replacement”(Attorney Docket No. 3645.144AWO), which are hereby incorporated byreference in their entirety herein.

FIG. 40 illustrates the distractor 200 along with a detachable paddle900, the detachable paddle 300, and an impact protector 800 for use ininstalling a tibial implant 20, according to an embodiment of thepresent disclosure. As shown in FIG. 40, the tibial implant 20 includesposts 22 or other projections that are received in the recesses earlierformed in the resected tibia such as described above. The impactprotector 800 is used to protect the tibial implant 20 while impacting.The impact protector 800 may be formed from a generally resilientmaterial. For example, the impact protector 800 may be formed form amaterial that is more resilient than the tibial implant 20. The impactprotector 800 may be formed from a material that is more resilient thanthe detachable paddle 900. In some embodiments, the impact protector 800may be formed from an implant grade UHMWPE (ultra-high-molecular-weightpolyethylene) material that is operable to protect the tibial implant 20while impacting. It will be appreciated that other polymeric or likematerial may be suitably employed.

With reference to FIGS. 41-48, the implant protector 800 may include abody 810 having a proximal portion 820 and a distal portion 840,according to an embodiment of the present disclosure.

As shown in FIG. 41, the distal portion 840 may be generally planar andinclude a projection or male portion 850 on the superior side. Theraised projection 850 may be a male portion that is configured to mateand be received in a corresponding recessed portion (not shown) of thetibial implant component 20 (FIG. 40). For example, the sides of theprojection 850 may include an undercut or otherwise be angled away (ortoward) from the periphery of the implant protector 800 to form asliding dovetail male portion which may engage the recessed portion ofthe tibial trial component 20 (e.g., a sliding dovetail socket/femaleportion). A distal edge 852 of projection 850 may allow for positioningof the impact protector 800 along the anterior-posterior directionrelative to the tibial implant component. For example, the recess in thetibial implant may have a corresponding distal edge. In anotherembodiment, the projection may have flat sides, (e.g., sides that arenormal or perpendicular to the superior planar surface of the impactprotector). Indicia 860 such as a number may be provided on the impactprotector to identify and correspond to the corresponding selected sizedtibial implant component. The distal portion 820 may provide a handle orend engageable by a surgeon for releasably attaching the impactprotector to the tibial implant.

FIGS. 49 and 50 illustrate the detachable paddle 900 for use with thedistractor 100 (FIG. 39) for installing the tibial component 20,according to an embodiment of the present disclosure. The detachablepaddle 900 may include a body 910 defining a proximal portion 920 and adistal portion 944. The proximal end 920 may be operably releasablyattachable to the distractor 100 (FIG. 39) as described above. Thedistal portion 940 may include a generally planar member having asuperior surface 950 (FIG. 49) and an inferior surface 945 (FIG. 50).With reference to FIG. 42, the distal portion 840 of the impactionprotector 800 may include a recessed hole or cavity 842 for receipt of acorresponding projection 942 (FIG. 49) on the superior surface 950 (FIG.49) of the detachable paddle 900 (FIG. 49). The detachable paddle 900may be usable with various sized and configured impact protectors.

FIG. 51 illustrates a surgical method 1000 for separating a first bonesurface from a second bone surface of an anatomical structure, accordingto an embodiment of the present disclosure. For example, method 1000 mayinclude at 1100 selecting a first paddle and a second paddle from aplurality of different paddles, at 1200 attaching the first paddle to afirst connector of a distractor, at 1300 attaching the second paddle toa second connector of the distractor, at 1400 inserting the first paddleand the second paddle between the first bone surface and the second bonesurface of the anatomical structure, and at 1500 operating thedistractor to force the first paddle away from the second paddle so asto force the first bone surface away from the second bone surface.

FIG. 52 illustrates a surgical method 2000 for installing an implant inan anatomical structure, according to an embodiment of the presentdisclosure. The method 2000 may include at 2010 providing an implanttrialing and cutting guide, at 2020 inserting the implant trialing andcutting guide between a resected portion of the first bone and the firstpaddle, at 2030 selecting a first detachable paddle and a detachablesecond paddle from a plurality of different paddles, at 2040 attachingthe first paddle to a first connector of a distractor, at 2050 attachingthe second paddle to a second connector of the distractor, at 2060inserting the first paddle and the second paddle between the first bonesurface and the second bone surface of the anatomical structure, and at2070 operating the distractor to seat the implant trialing and cuttingguide in the resected portion of the first bone.

The method may further include at 2080, selecting a third detachablepaddle having at least one punch pin, at 2090 removing the firstdetachable paddle from the first connector of the distractor, at 2100attaching the third detachable paddle to the first connector of thedistractor, at 2110 passing the at least one punch pin through theimplant trial component seated in the resected portion of the firstbone, and at 2120 using the distractor to force the at least one cuttingand/or punch pin into the resected portion of the first bone.

FIGS. 53 and 54 illustrate an implant impaction system 3000 for use ininstalling the tibial implant component 20 (FIG. 53), according to anembodiment of the present disclosure. For example, the implant impactionsystem 3000 may be a tibial implant impaction system for use ininstalling a tibial implant component in a TAR. In this illustratedembodiment, as shown in FIGS. 55-61, the implant impaction system 3000may include a body 3100, a detachable projecting member 3200, and theimpaction protector 800 (FIG. 53).

With reference to FIG. 55, the body 3100 may have a generally U-shapedconfiguration defining a central or middle handle portion 3120, animpact portion 3130, and a distal portion 3140 operable for releasablyconnecting to the projecting member 3200. The detachable projectingmember 3200 may have a proximal portion 3202 and a distal portion 3204.The proximal portion 3202 may be releasably attachable to the distalportion 3140 of the body 3100. In some embodiments, the U-shapedconfiguration of the body may be disposed along a plane, and when thedetachable projected member 3200 is attached to the distal portion 3140of the body 3100, a distal end 3208 of the projection member 3204 isoffset from the plane as best shown in FIG. 60.

With reference again to FIG. 53, the impaction protector 800 issupportable on the distal portion 3204 of the detachable projectingmember 3200. The impaction protector 800 is positionable between thetibial implant component 20 and the detachable projecting member 3200during implanting of the tibial implant component 20. The impactionprotector 800 is further shown in FIGS. 41-48 and described above.

With reference again to FIG. 55, the distal portion 3204 of thedetachable projecting member 3200 may include a pin 3242 which isreceivable in the cavity 842 (FIG. 42) of the impaction protector 800(FIG. 42). The proximal portion 3130 may include an enlarged knob 3135.The implant impaction system 3000 may be used with traditional impactioninstruments such as a hammer. The implant impactor system 3000 mayinclude a plurality of differently sized and configured impactionprotectors, each of which being supportable on the distal portion of theprojecting member.

FIGS. 62-69 illustrate a detachable tibial paddle 4300, according to anembodiment of the present disclosure. In this exemplary embodiment, thedetachable tibial trial paddle 4300 may be a universally sizeddetachable tibial paddle with an anti-rotation feature operable to nestinside or mate with a dovetail of a tibial trialing implant component(not shown).

In this illustrated embodiment, for example, the detachable tibialpaddle 4300 may include a body 4310 having a proximal portion 4320 and adistal portion 4340. With reference to FIGS. 62 and 63, the detachabletibial paddle 4300 may be configured to releasably attach to a firstpost 4293 (FIG. 70) and/or a second post 4294 (FIG. 70) of a distractor4200 (FIG. 70). The distal portion 4340 may include a generally planarmember having a raised center portion 4342 (FIG. 62) having a first ortop planar surface 4347 surrounded by a recessed peripheral surface4343. The peripheral edge 4345 of the raised center portion 4342 (FIG.62) of the detachable tibial paddle 4300 may be normal or at a rightangle to the surface of the recessed peripheral portion 4343. The distalportion 4340 may include the generally planar member having a second orbottom planar surface 4344 (FIG. 63).

The proximal portion 4320 of the detachable tibial paddle 4300 mayinclude a recess 4322, which is supportable on the posts of thedistractor 4200 (FIG. 70). The recess 4322 may have a squarecross-section. The proximal portion 4320 may also include a cutout 4324for receiving a laterally-extending projection 4295 (FIG. 70) on post4293 (FIG. 70) and/or a laterally-extending projection (not shown inFIG. 70) on post 4294.

As shown in FIG. 63, the second planar surface 4344 of the detachablepaddle 4300 may include a first raised land 4346 extending from thesecond planar surface 4344 and a second raised land 4347 extending fromthe second planar surface 4344. With reference to FIGS. 63 and 64, theproximal portion 4320 of the detachable tibial paddle 4300 may define alongitudinal axis L4 (FIG. 62) and the planar member 4340 of thedetachable tibial paddle 4300 may define a longitudinal axis L5 (FIG.62). As shown in FIG. 62, the longitudinal axis L4 of the planar member4340 may be offset from the longitudinal axis L5 of the proximal portion4320. As shown in FIG. 63, the second planar surface 4344 of thedetachable tibial paddle 4300 may include a transverse cutout 4341,which as described below, and which defines a centralizing radiographicmarker. The raised land 4346 may be an elongated raised land that isdisposed on one side of the longitudinal axes L4 (FIG. 62) and L5 (FIG.62) of the body 4310.

With reference to FIGS. 71 and 72, a tibial trialing implant component4400 may be essentially the same as tibial trialing implant component400 (FIGS. 20 and 21). The tibial trialing implant component 4400 mayinclude a base portion 4420 and an arm or wing portion 4440. A distalside of the base portion 4420 may include a distal recessed portion 4430(FIG. 71). As shown in FIGS. 73 and 74, the raised center portion 4342(FIG. 74) of the detachable paddle 4300 may nest or mate within therecessed portion 4430 (FIG. 71) of the tibial trialing implant component4400. The edge 4345 (FIG. 62), the raised center portion 4342 (FIG. 62)may contact against the recessed sides of the recessed portion 4430(FIG. 71) to inhibit rotation between the detachable paddle 4300 and thetibial trialing implant component 4400 once nested or mated together. Asshown in FIG. 74, the base portion 4420 of the tibial trialing implantcomponent 4400 may include a transverse cutout 4421 defining acentralizing radiographic marker, which is alignable with the transversecutout 4341 of the detachable tibial paddle 4300.

With reference again to FIG. 71, the sides of the recessed portion 4430may include an undercut or otherwise be angled toward (or away) theperiphery of the base portion 4420 as they extend proximally to a planarproximal end surface to form a sliding dovetail socket or female portionfor receiving a corresponding portion of a trialing insert (not shown).In some embodiments, the lateral sides of the raised center portion maybe correspondingly angled and configured to form, for example, a dovetail connection.

The detachable tibial paddle may be provided in different sizes andconfigurations. For example, as shown in FIGS. 75 and 76, a firstdetachable tibial paddle 4301 may be sized and configured to allowcentering the talus relative to the tibia. A second detachable tibialpaddle 4302 may be sized and configured to allow posterior translationof up to about 4 millimeters. For example, the length of the paddles maybe different.

FIG. 77 illustrates a distal portion of the distractor 4200, adetachable tibial paddle 4300, and a detachable talus paddle 4600,according to an embodiment of the present disclosure. The distractor4200 may be essentially the same as the distractor 200 (FIG. 2) with theexception of the first post 4295 and the second post (not shown in FIG.77) having side laterally-extending projections. For example, the firstlaterally extending projection 4295 may extend to one side of thedistractor 4200 for use in securing the detachable tibial paddle 4300. Asecond laterally extending projection (not shown) may extend to theother side of the distractor 4200 for use in securing the detachabletalus paddle 4600. As shown in FIG. 78, various sized and configureddetachable talus paddles 4601, 4602, and 4603 may be provided having,for example, different sized or width distal portions.

With reference to FIG. 79, a detachable talus paddle 4604 may include atransverse cutout 4641, which defines a centralizing radiographicmarker. As shown in FIG. 79, the transverse cutout 4641 of thedetachable talus paddle 4604, the transverse cutout 4341 of thedetachable tibial paddle 4300, and the transverse cutout 4421 of thetibial trialing implant component 4400 may be aligned.

FIGS. 80 and 81 illustrate a detachable peg punch paddle 4500, accordingto an embodiment of the present disclosure. In this illustratedembodiment, the detachable peg punch paddle 4500 is essentially the sameas the detachable punch paddle 4300 (FIGS. 62 and 63) with the exceptionof the shape and configuration of a plurality of pins 4502. For example,as shown in FIG. 82, the distractor 4200 along with the detachabletibial paddle 4300, the tibial trialing implant component 4400, and thedetachable talus paddle 4604 may be employed with the cutting and/orpunch pins 4502 which are operable to form openings in the distalresected tibia to accommodate at least one peg of a corresponding tibialimplant component therein.

As shown in FIG. 83, in this illustrated embodiment, the punch pin 4502may include deep, aggressive longitudinal serrations to aid in bonepreparation. For example, the cutting and/or punch pin 4502 may includelongitudinal serrations that extends a distance H, which is greater thanthe radius R of the cutting and/or punch pin 4502. In some embodiments,the distance H of the longitudinal serrations may be about twice, ormore of the radius R of the cutting and/or punch pin. The cutting and/orpunch pins 4502 may include six radial cutting edges 4510 that angledownwardly from the center to the periphery of the cutting and/or punchpin 4502.

FIGS. 84 and 85 illustrate an impaction protector 4800 and FIGS. 86 and87 illustrate a detachable tibial implantation paddle 4900 that arenestable together for use in installing a tibial implant component,according to an embodiment of the present disclosure. The impactionprotector 4800 and the detachable tibial impaction paddle 4900 areusable with a distractor for installing a tibial implant component, asdescribed in greater detail below.

With reference again to FIGS. 84 and 85, the impaction protector 4800may include a body 4810 having a proximal portion 4820 and a distalportion 4840. As shown in FIG. 84, the distal portion 4840 may begenerally planar and include a projection or male portion 4850 on thesuperior side. The raised projection 4850 may be a male portion that isconfigured to mate and be received in a corresponding recessed portionof a tibial implant component such as the tibial implant component 20(FIG. 88). For example, the sides of the projection 4850 may include anundercut or otherwise be angled away (or toward) from the periphery ofthe implant protector 4800 to form a sliding dovetail male portion whichmay engage the recessed portion of the tibial implant component (e.g., asliding dovetail socket/female portion). A distal edge 4852 of theprojection 4850 may allow for positioning of the impaction protector4800 along the anterior-posterior direction relative to the tibialimplant component. For example, the recess in the tibial implantcomponent may have a corresponding distal edge. The distal portion 4820may provide a handle or end engageable by a surgeon for releasablyattaching the impaction protector 4800 to the tibial implant component.In addition, a cutout 4870 may be provided in the handle to provideclearance for the proximal portion of the detachable tibial implantationpaddle 4900 (FIGS. 86 and 87) as further described below. In anotherembodiment, the projection 4850 may have flat sides, (e.g., sides thatare normal or perpendicular to the superior planar surface of theimpaction protector 4800. Indicia 4860 such as a number may be providedon the impaction protector to identify and correspond to thecorresponding selected sized tibial implant component. Interferencefeatures 4890 (FIG. 84) may be provided, e.g., stick fit to theimpaction protector 4800.

As shown in FIG. 85, the distal portion 4840 of the impaction protector4800 may include a recessed elongated cavity 4880 having a firstrecessed surface 4882, and a second center recessed surface 4884 fornesting or mating with the superior surface 4984 (FIG. 86) of thedetachable tibial implantation paddle 4900 (FIG. 86). The second centerrecessed surface 4884 of impaction protector 4800 may include a hole4886 for use with a bossed implant impaction system 5000 (FIG. 90)described below. The impaction protector 4800 is used to protect thetibial implant component 20 while impacting and may be formed from agenerally resilient material. For example, the impaction protector 4800may be formed from a material that is more resilient than the tibialimplant component 20. For example, the impaction protector 4800 may beformed from a material that is more resilient than the detachable tibialimplantation paddle 4900. In some embodiments, the impaction protector4800 may be formed from an implant grade UHMWPE(ultra-high-molecular-weight polyethylene) material that is operable toprotect the tibial implant component 20 while impacting. It will beappreciated that other polymeric or like material may be suitablyemployed.

With reference to FIGS. 86 and 87, the detachable tibial implantationpaddle 4900 is operable for use with the impaction protector 4800 (FIG.84) in, for example, for installing a tibial implant component. Thedetachable tibial implantation paddle 4900 may include a body 4910defining a proximal portion 4920 and a distal portion 4944. The proximalportion 4920 may be operably releasably connectable to the distractor4200 (FIG. 88). The distal portion 4940 may include a generally planarmember having a superior surface 4950 (FIG. 86) and an inferior surface4945 (FIG. 87). As shown in FIG. 86, the superior portion of the distalportion 4940 of the detachable tibial implantation paddle 4900 mayinclude the elongated raised center portion 4984, and a recessedperipheral edge portion 4982. As shown in FIG. 87, the inferior portionof the distal portion 4940 of the detachable tibial implantation paddle4900 may include an impaction tool locator or recessed hole or cavity4942.

FIG. 88 illustrates an assembly for implanting the tibial implantcomponent 20, according to an embodiment of the present disclosure. Thedistractor 4200 along with the detachable tibial implantation paddle4900, the impaction protector 4800, and a detachable talus paddle 4606are operable for use in installing the tibial implant component 20. Forexample, the tibial implant component 20 includes posts 22 or otherprojections that are received in the recesses earlier formed in theresected tibia such as described above. FIGS. 89 and 90 illustrates theproximal portion 4920 of the detachable tibial implantation paddle 4900disposed in the cutout 4870 of the impaction protector 4800.

With reference to FIG. 91, therein illustrated is an implant impactionsystem 5000, according to an embodiment of the present disclosure. Theimplant impaction system 5000 may include a body 5100 and a detachableprojecting member 5200. The implant impaction system 5000 may beessentially the same as the implant impaction system 3000 (FIG. 54)described above.

In this illustrated embodiment, as shown in FIG. 92, the detachableprojecting member 5200 may include a proximal portion 5202 and a distalportion 5204. The proximal portion 5202 may be releasably attachable toa distal portion 5140 (FIG. 91) of the body 5100 (FIG. 91). In someembodiments, the U-shaped configuration of the body 5100 may be disposedalong a plane, and when the projected member 5200 is attached to thedistal portion 3140 of the body 3100, a distal end 5208 of thedetachable projection member 5204 is offset from the plane.

The distal portion 5204 of the detachable projecting member 5200 mayinclude an enlarged circular disc portion 5241 with a center pin 5245,which as shown in FIG. 93, the center pin 5245 is received in the hole4942 of the detachable tibial implantation paddle 4900, which thedetachable tibial implantation paddle 4900 is attached to the distractor(not shown in FIG. 93). With reference still to FIG. 93, for example,the diameter of the circular disc portion 5241 may be sized about equalto a width W1 (FIG. 87) of the detachable tibial implantation paddle4900. With reference again to FIG. 91, a proximal portion 5130 mayinclude an enlarged knob 5135. The implant impaction system 5000 may beused with traditional impaction instruments such as a hammer. Theimplant impactor system 5000 may include a plurality of differentlysized and configured detachable impaction protectors, each of whichbeing supportable on the distal portion of the implant impaction system5000. As shown in FIG. 102, the implant impaction system 5000 with theprojecting member 5200 may be employed with the distractor 4200 forimplanting a tibial implant component.

FIG. 94 illustrates another embodiment of a detachable projecting member5201 that may include a proximal portion 5202 and a distal portion 5205.The proximal portion 5202 may be releasably attachable to a distalportion 5140 (FIG. 91) of the body 5100 (FIG. 91) of the implantimpaction system 5000. In this illustrated embodiment, the distalportion 5205 of the detachable projecting member 5200 may include anenlarged circular disc portion 5241 with a flat surface 5246, which asshown in FIG. 94, the circular disc portion 5241 is receivable in thecavity 4880 of the impaction protector 4800. The diameter of thecircular disc portion 5246 may be sized slightly less than the width Wof the cavity 4880.

FIGS. 96 and 97 illustrate a detachable talar implant trialing andcutting guide 4700 for use with a direct connection to the distractor4200 as shown in FIG. 98, according to an embodiment of the presentdisclosure. With reference again to FIGS. 96 and 97, the detachabletalar implant trialing and cutting guide 4700 may include a body 4710having a proximal portion 4712 and a distal portion 4714. The proximalportion 4712 may be configured for directly releasably attaching to alower post 4294 (FIG. 70) of the distractor 4200 (FIG. 98). As bestshown in FIG. 96, a superior surface 4740 of the detachable talarimplant trialing and cutting guide 4700 may include a curved surface4740. Other features of the detachable talar implant trialing andcutting guide 4700 may generally include a cut slot 4750, pin apertures4752 and 4753, and a window or aperture 4756 extending therethrough. Thepin apertures 4752 and 4753 may be configured to accept a pin, k-wire orother bone fixation member therethrough and into a talus. The cut slot4750 can be utilized as a cut guide for the removal of a posteriorportion of the talus that extends (and therefore is angled) distally andposteriorly from the resected proximal surface of the talus. Theanterior window 4756 may be positioned over the anterior side of a talussuch that the window 4756 can be utilized with a cut guide for theremoval of an anterior portion of the talus that extends (and thereforeis angled) distally and anteriorly from the resected surface of thetalus. It will be appreciated that differently sized detachable talarimplant trialing and cutting guides 4700 may include differinganterior-posterior lengths, medial-lateral widths and/or proximal-distalthicknesses. The talar implant trialing and cutting guides 4700 may bethe same or similar to the talar implant trialing and cutting guidesdescribed in U.S. provisional application No. 62/779,092, entitled“Instruments, Guides And Related Methods For Total Ankle Replacement”(Attorney Docket No. 3645.144P), and International PCT PatentApplication, filed Dec. 13, 2019, entitled “Instruments, Guides AndRelated Methods For Total Ankle Replacement” (Attorney Docket No.3645.144AWO), which are hereby incorporated by reference in theirentirety herein.

FIGS. 99 and 100 illustrate a detachable flat talus implant trialing andcut guide 6700 for use with a direct connection to the distractor 4200as shown in FIG. 101, according to an embodiment of the presentdisclosure. With reference again to FIGS. 99 and 100, the detachableflat talus implant trialing and cut guide 6700 may include a body 6710having a proximal portion 6712 and a distal portion 4714. The proximalportion 4712 may be configured for directly releasably attaching to alower post 4294 (FIG. 70) of the distractor 4200 (FIG. 101).

The detachable flat talus implant trialing and cut guide 6700 mayinclude an articulation surface 6740 that corresponds to a talar implantcomponent (not shown) that contacts and articulates (via sliding/glidingmotion) with that of a corresponding tibial insert (not shown). Thearticulation surface 6740 of the detachable flat talus implant trialingand cut guide 6700 may thereby provide a close approximation of thearticulation surface of the corresponding talar component such that thesize and range of motion of the corresponding talar component be testedor trialed via the articulation surface 6740 of the flat talus trialcomponent 6700.

The detachable flat talus implant trialing and cut guide 6700 mayinclude at least one drill guide through-hole 6780 for use by a surgeonin forming holes in the resected talus for the pegs of a talar implantcomponent.

In the various described embodiments of the present disclosure. thevarious components may be formed from a metal and/or polymeric material.The connection of the paddles to the distractor, and the connection ofthe projecting member to the implant impaction system may have othersuitabley sized and configured matingly-engaging portions such ascircular posts or other shaped poses and recesses, be releasablyconnectable in a snap fit manner or with a snapfit connector, bethreadably releasably connectable, or may be assembled and attached inany suitable suitable manner. In some embodiments, one of the paddlesmay be fixed and integral with the distractor.

It will be appreciated that the above described detachable tool may beinterchangeable and usable on both the distractors and the body of theimplant impaction system.

An embodiment of a surgical procedure using the above describedcomponents may be as follows. A tibial trailing implant component may becorrespondingly sized to a sizing resection block (not shown). By hand,the tibial trailing implant component may be slid over twomedial/lateral pins such as 2.4 mm smooth Steinmann Pins on the anterioraspect of the distal tibia, which pins were earlier installed and usedto support the sizing resection block. The tibial trailing implantcomponent may be inserted such that the anterior surface of the tibialtrailing implant component is approximately flush to the anterior tibia.The pins in the slots are centered to ensure appropriate varus/valgusand superior/inferior placement against the inferior surface of thetibia. A 4-Bar Parallel Distractor such as the distractors describedabove may be used to distract the tibiotalar joint and confirm theprovisional tibial trailing implant component position using AP andlateral fluoro. The center of a tibial trial notch (e.g., notch 429 inFIG. 20) may be aligned with the posterior tibia wall. A long tibia sizemay be desired if uncertain whether the notch of the tibia trial islocated within the tibia or not. Full anterior/posterior coverage withminimal overhang may be desired. The tibial trailing implant componentis tightened against the anterior tibia by rotating a distal most setscrew on the tibia trial clockwise until the tibia trial and anteriortibia are flush. Using a lateral fluoro view, the tibia implant lengthis determined. The notch of the tibial trial comes into view on thelateral view. If the notch is located beyond the posterior tibia, aregular tibia size should be used. If the notch is located within thetibia, a long tibia size may be used.

Once sizing of the tibial trailing implant component has been evaluated,the distractor with detachable paddles are used so that the paddles arereceived in the resected tibiotalar joint. For example, the superiorpaddle's dovetail connection may be operably slid into the inferioraspect of the tibial trailing implant component. The joint is distractedby squeezing down on the handle of the distractor to apply even pressureagainst the tibial trailing implant component and the talar corticalsurface to fully seating the tibial trial into position. The tibialtrailing implant component position may be checked on AP and lateralfluoro views to ensure position and fit. With the distractor in place,threaded shoulder pins may be inserted into two of the 4 proximalconverging pin holes (e.g., two of holes 441 in the tibial trailingimplant component 400) using a one of the holes on each side.

In one embodiment, with the converging shoulder pins in place, thedistractor is removed from the tibiotalar joint. The correspondingdetachable paddle is replaced with the detachable punch paddle (e.g.,such as detachable detachable peg punch paddle 500 (FIG. 25) ordetachable peg punch paddle 4500 (FIG. 80)) corresponding to theselected tibial trailing implant component and operably attached to thedistractor.

The distractor is inserted into the resected tibiotalar joint, ensuringthat the detachable punch paddle is facing superiorly. The punch pinsare aligned with the inferior holes in the tibial trailing implantcomponent and position is verified using AP and lateral fluoro as wellas visually. The surgeon may begin to distract the distractor underlateral fluoroscopy.

Using the previously assembled construct (e.g., assembly 7000 as shownin FIG. 102), insert the impaction dimple (e.g., projection 5245 shownin FIG. 92) underneath the punch paddle. The distal end of the impactionassembly is impacted, still under the distractor until the punch paddleis fully seated.

In another embodiment, the distraction need not be used but just theimpactions assembly. In this embodiment, for example, the detachablepunch paddle may be aligned with the holes in the tibial trailingimplant component. The impaction handle is attached to the detachablepunch paddle. Both visually and under fluoro, the detachable punchpaddle is perpendicular to the long axis of the tibia (e.g., the punchpins being parallel to the long axis of the tibia) and verifyingposition using AP and lateral view. Under fluoro, a mallet is used(e.g., two to four strikes) on the distal end of the impaction handle toimpact the punch pins into the tibia. Confirmation may be made thatcomplete seating of the punch pins has occurred relative to the tibialtrailing implant component by direct visualization under fluoroscopy.

An embodiment of a chamfer-cut, talar trial positioning may be asfollows. By hand, a surgeon may initially place the detachable talustrialing implant and cut guide into the joint to evaluate coverage.Visually and under fluoro, confirmation of the guide size in assessingcoverage on talus, ensuring that the guide adequately covers the medialand lateral aspect of the dorsal cut without impinging on the guttersand vertical line on trial aligns with the lateral process. Once sizinghas been evaluated, the guide may be removed and attached to adistractor. The talus trialing implant and cut guide is reinserted intothe resected tibiotalar joint, matching a superior paddle's dovetailconnection to an inferior aspect of a tibial implant trialing andcutting guide and the inferior aspect of the talus trialing implant andcut guide to the resected talar bone (e.g., construct as shown in FIG.98) disposed in the joint.

The joint is distracted by squeezing down on the distractor handle,applying even pressure against the tibial/talar trial guides and thetibiotalar cortical surfaces preparing to fully seat the talus trialingimplant and cut guide into position. With the parallel distractor inplace, re-check the talus trialing implant and cut guide position undera lateral fluoro view to ensure position and fit before setting intoplace with shoulder pins. The selected talus trialing implant and cutguide can be sized up or down to achieve appropriate coverage.Plantarflexing the tibiotalar joint to achieve appropriate visualizationbefore setting in place may be desired. Under the same view, ensure thatthe cutting slots for the anterior and posterior chamfers are resectingan appropriate amount of talus. With the talus trialing implant and cutguide attached to the 4-Bar Parallel Distractor and positioned in place,is followed by subsequent pin fixation steps. Pins such as 2.4 mm smoothSteinmann pin may be placed into the medial anterior hole in the talustrialing implant and cut guide and retrieve (2) threaded shoulder pins.Plantarflex the foot to expose the converging pin holes located moreposteriorly on the guide. Under power, place the medial anterior pininto the guide, stopping pin insertion prior to touching the shoulderagainst the guide. Under power, place a first shoulder pin into themedial hole of the Sizing Resection Guide. Place a second shoulder pininto the lateral hole of the guide. Advance the shoulder pins slowlyusing a ream setting. Disconnect the distractor handle, then using pincutters, trim the medial anterior 2.4 mm smooth Steinmann Pin. Also, ifnot previously cut, trim the central pins on the tibial trial flush tothe anterior surface to provide clearance for a talar plunging reamer.

The posterior talar chamfer cut may include evaluating access to theposterior cut slot within the talus trialing implant and cut guide. Ifaccess to the posterior cut slot is favorable, an oscillating saw blademay be used for the dorsal talar cut. Insert the saw blade into theposterior cut slot of the talus trialing implant and cut guide. Underpower, the posterior saw cut is performed, taking care to avoid contactwith the medial malleolus and fibula.

For a chamfer-cut talar bone resection a 2-holed resection insert (e.g.,insert 8000 as shown in FIG. 103) may be placed, corresponding to thesize of the sizing resection guide, into the anterior window of thetalus trialing implant and cut guide. A plunging reamer may be placedinto one of the two anterior holes, holding it perpendicular to the2-holed resection insert. Wait to start the reamer until lightly pressedagainst the cortical bone, and under power, ream until the plungingreamer bottoms out against the 2-holed resection insert. Then, repeatthis reaming step for the second anterior hole, then remove the 2-holedresection Insert. A single-slotted resection insert (e.g., insert 8100as shown in FIG. 104) may be placed in the anterior window of the talustrialing implant and cut guide. Using the plunging Reamer, slide thereamer from left to right until the bridge between the two reamed holesis resected, then remove the single-slotted resection insert.Thereafter, the threaded shoulder pins are removed from the talustrialing implant and cut guide, the medial anterior pin is removed fromthe talus trialing implant and cut guide as well, then the talustrialing implant and cut guide is removed. The chamfer cut may bechecked and fin reamed. Sizing and cutting procedures that may beapplicable to the use of the components disclosed above are shown anddescribed in U.S. provisional application No. 62/779,092, entitled“Instruments, Guides And Related Methods For Total Ankle Replacement”(Attorney Docket No. 3645.144P), and International PCT PatentApplication, filed Dec. 13, 2019, entitled “Instruments, Guides AndRelated Methods For Total Ankle Replacement” (Attorney Docket No.3645.144AWO), which are hereby incorporated by reference in theirentirety herein.

The above disclosure describes a portion of a total ankle replacement(TAR) procedure and the devices used in that procedure. Additionalunderstanding of the TAR procedure may be found in U.S. ProvisionalApplication No. 62/779,436 filed Dec. 13, 2018, and entitled JointReplacement Systems and Methods of Use and Assembly (Attorney Docket No.3645.138P1), International Application No. PCT/US2019/029009 filed Apr.24, 2019, and entitled Implants and Methods of Use and Assembly(Attorney Docket No. 3645.139AWO), U.S. Provisional Application No.62/779,092 filed Dec. 13, 2018, and entitled Instruments, Guides andRelated Methods for Total Ankle Replacement (Attorney Docket No.3645.144P), International Application No. PCT/US2019/066404 filed Dec.13, 2019, and entitled Instruments, Guides and Related Methods for TotalAnkle Replacement (Attorney Docket No. 3645.144AWO), U.S. ProvisionalApplication No. 62/890,611 filed Aug. 22, 2019, and entitled PatientSpecific Instruments and Methods of Use (Attorney Docket No. 3645.152P),International Application No. PCT/US2019/066336 filed Dec. 13, 2019, andentitled Patient Specific Instruments and Methods of Use (AttorneyDocket No. 3645.152AWO), U.S. Provisional Application No. 62/899,703filed Sep. 12, 2019, and entitled Joint Replacement Alignment Guides,Systems and Methods of Use and Assembly (Attorney Docket No.3645.155P1), International Application No. PCT/US2019/066408 filed Dec.13, 2019, and entitled Joint Replacement Alignment Guides, Systems andMethods of Use and Assembly (Attorney Docket No. 3645.155AWO), U.S.Provisional Patent Application No. 62/899,655, filed Sep. 12, 2019, andentitled Alignment Instruments And Methods For Use In Total AnkleReplacement (Attorney Docket No. 3645.156P1), International ApplicationNo. PCT/US2019/066149, filed on Dec. 13, 2019, and entitled AlignmentInstruments And Methods For Use In Total Ankle Replacement (AttorneyDocket No. 3645.156AWO), U.S. Provisional Application No. 62/899,740filed Sep. 12, 2019, and entitled Joint Replacement Alignment Guides,Systems and Methods of Use and Assembly (Attorney Docket No.3645.157P1), International Application No. PCT/US2019/066393 filed Dec.13, 2019, and entitled Joint Replacement Alignment Guides, Systems andMethods of Use and Assembly (Attorney Docket No. 3645.157AWO), U.S.Provisional Application No. 62/898,615 filed Sep. 11, 2019, and entitledResection Guides, Sweeping Reamers, and Methods for Use in Total AnkleReplacement (Attorney Docket No. 3645.158P1), International ApplicationNo. PCT/US2019/064948 filed Dec. 6, 2019, and entitled Resection Guides,Sweeping Reamers, and Methods for Use in Total Ankle Replacement(Attorney Docket No. 3645.158AWO), U.S. Provisional Application No.62/898,854 filed Sep. 11, 2019, and entitled Distractors HavingAttachable Paddles, Impaction Devices, and Methods for Use in TotalAnkle Replacement (Attorney Docket No. 3645.159P1), InternationalApplication No. PCT/US2019/066398 filed Dec. 13, 2019, and entitledDistractors Having Attachable Paddles, Impaction Devices, and Methodsfor Use in Total Ankle Replacement (Attorney Docket No. 3645.159AWO),U.S. Provisional Application No. 62/899,646 filed Sep. 12, 2019, andentitled Trial Insert Assembly (Attorney Docket No. 3645.160P1),International Application No. PCT/US2019/065025 filed Dec. 6, 2019, andentitled Trial Insert Assembly (Attorney Docket No. 3645.160AWO), U.S.Provisional Application No. 62/899,460 filed Sep. 12, 2019, and entitledTotal Ankle Replacement Surgical Method (Attorney Docket No.3645.161P1), International Application No. PCT/US2019/066409 filed Dec.13, 2019, and entitled Total Ankle Replacement Surgical Method (AttorneyDocket No. 3645.161AWO), which are each hereby incorporated herein intheir entireties.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the presentdisclosure. As used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprise” (and any form of comprise, such as “comprises” and“comprising”), “have” (and any form of have, such as “has” and“having”), “include” (and any form of include, such as “includes” and“including”), “contain” (and any form contain, such as “contains” and“containing”), and any other grammatical variant thereof, are open-endedlinking verbs. As a result, a method or article that “comprises”, “has”,“includes” or “contains” one or more steps or elements possesses thoseone or more steps or elements, but is not limited to possessing onlythose one or more steps or elements. Likewise, a step of a method or anelement of an article that “comprises”, “has”, “includes” or “contains”one or more features possesses those one or more features, but is notlimited to possessing only those one or more features. Any examples ofparameters are not exclusive of other parameters of the disclosedembodiments.

As used herein, the terms “comprising,” “has,” “including,”“containing,” and other grammatical variants thereof encompass the terms“consisting of” and “consisting essentially of.” The phrase “consistingessentially of” or grammatical variants thereof when used herein are tobe taken as specifying the stated features, integers, steps orcomponents but do not preclude the addition of one or more additionalfeatures, integers, steps, components or groups thereof but only if theadditional features, integers, steps, components or groups thereof donot materially alter the basic and novel characteristics of the claimedcompositions or methods.

All publications cited in this specification are herein incorporated byreference as if each individual publication were specifically andindividually indicated to be incorporated by reference herein as thoughfully set forth.

Where one or more ranges are referred to throughout this specification,each range is intended to be a shorthand format for presentinginformation, where the range is understood to encompass each discretepoint within the range as if the same were fully set forth herein.

It is to be understood that the above description is intended to beillustrative, and not restrictive. Numerous changes and modificationsmay be made herein by one of ordinary skill in the art without departingfrom the general spirit and scope of the invention as defined by thefollowing claims and the equivalents thereof. For example, theabove-described embodiments (and/or aspects thereof) may be used incombination with each other. In addition, many modifications may be madeto adapt a particular situation or material to the teachings of thevarious embodiments without departing from their scope. While thedimensions and types of materials described herein are intended todefine the parameters of the various embodiments, they are by no meanslimiting and are merely exemplary. Many other embodiments will beapparent to those of skill in the art upon reviewing the abovedescription. The scope of the various embodiments should, therefore, bedetermined with reference to the appended claims, along with the fullscope of equivalents to which such claims are entitled.

In the appended claims, the terms “including” and “in which” are used asthe plain-English equivalents of the respective terms “comprising” and“wherein.” Moreover, in the following claims, the terms “first,”“second,” and “third,” etc. are used merely as labels, and are notintended to impose numerical requirements on their objects. Also, theterm “operably connected” is used herein to refer to both connectionsresulting from separate, distinct components being directly orindirectly coupled and components being integrally formed (i.e.,monolithic). Further, the limitations of the following claims are notwritten in means-plus-function format and are not intended to beinterpreted based on 35 U.S.C. § 112, sixth paragraph, unless and untilsuch claim limitations expressly use the phrase “means for” followed bya statement of function void of further structure.

It is to be understood that not necessarily all such objects oradvantages described above may be achieved in accordance with anyparticular embodiment. Thus, for example, those skilled in the art willrecognize that the systems and techniques described herein may beembodied or carried out in a manner that achieves or optimizes oneadvantage or group of advantages as taught herein without necessarilyachieving other objects or advantages as may be taught or suggestedherein.

While the invention has been described in detail in connection with onlya limited number of embodiments, it should be readily understood thatthe invention is not limited to such disclosed embodiments. Rather, theinvention can be modified to incorporate any number of variations,alterations, substitutions or equivalent arrangements not heretoforedescribed, but which are commensurate with the spirit and scope of theinvention. Additionally, while various embodiments of the invention havebeen described, it is to be understood that aspects of the disclosuremay include only some of the described embodiments.

Components, aspects, features, configurations, arrangements, uses andthe like described, illustrated or otherwise disclosed herein withrespect to any particular embodiment may be similarly applied to anyother embodiment disclosed herein. Accordingly, the inventions are notto be seen as limited by the foregoing description, but is only limitedby the scope of the appended claims.

This written description uses examples to disclose the inventions,including the best mode, and also to enable any person skilled in theart to practice the inventions, including making and using any devicesor systems and performing any incorporated methods. The patentable scopeof the inventions are defined by the claims, and may include otherexamples that occur to those skilled in the art. Such other examples areintended to be within the scope of the claims if they have structuralelements that do not differ from the literal language of the claims, orif they include equivalent structural elements with insubstantialdifferences from the literal language of the claims.

What is claimed is:
 1. A distractor system for use in a joint betweentwo bone surfaces of an anatomical structure, said distractor systemcomprising: a first pivotable member having a first user engageable armand an opposite first end; a second pivotable member having a seconduser engageable arm and an opposite second end, said first pivotablemember pivotably connected to said second pivotable member between saiduser engageable arms and said ends; a first connecting member having afirst end and a second end, said first end pivotally connected to saidfirst end of said first pivotable member; a second connecting memberhaving a first end and a second end, said first end pivotally connectedto said second end of said second pivotable member; a biasing member forbiasing said first arm away from said second arm so that said second endof said first connecting member is biased towards said second end ofsaid second member; at least one detachable tool comprising a bodyhaving a proximal portion and a distal portion, said proximal portionbeing releasably attachable to at least one of said second end of saidfirst connection member and/or said second end of said second connectingmember, said distal portion being operably positionable in the jointbetween the two bone surfaces of the anatomical structure; said at leastone detachable tool comprising a distal portion comprising at least onecutting and/or punch pin; and said at least one cutting and/or punch pincomprising longitudinal serrations that extends a distance greater thana radius of the at least one cutting and/or punch pin.
 2. The distractorsystem of claim 1, wherein said at least one cutting and/or punch pincomprises a plurality of cutting and/or punch pins disposedperpendicular to a longitudinal axis of said distal portion.
 3. Thedistractor system of claim 1, wherein said proximal portion comprise afirst longitudinal axis and said distal portion comprises a secondlongitudinal axis offset from said first longitudinal axis.
 4. Thedistractor system of claim 1, wherein said distal portion comprisesradiographic marker.
 5. The distractor system of claim 1, wherein saidat least one detachable tool further comprises a plurality of detachablepaddles, a detachable resection guide, and a detachable implant trialingand cutting guide.
 6. The distractor system of claim 1, wherein saidsecond end of said first connecting member comprises a first post, andsaid second end of said second connecting member comprises a secondpost.
 7. The distractor system of claim 6, wherein said first postcomprises a first axis, said second post comprises a second axis, andsaid first axis being maintained parallel to said second axis.
 8. Thedistractor system of claim 1, wherein said second end of said firstconnecting member comprises a first post having a laterally-extendingprojection, and said second end of said second connecting membercomprises a second post having a laterally-extending projection.
 9. Thedistractor system of claim 1, further comprising a ratchet pivotallyattached to said second arm and selectively releasably attachable tosaid first arm, and a scissors mechanism for connecting said firstconnecting member to said second connecting member and operably movablyto maintain said first connecting member parallel to said secondconnecting member.
 10. The distractor system of claim 1, wherein said atleast one detachable tool is sized for being received between two bonesurfaces of an ankle joint.
 11. The distractor system of claim 1,wherein said at least one detachable tool is sized for being receivedbetween a tibia and a talus of an ankle joint.
 12. A surgical methodcomprising: providing the distractor of claim 1; attaching the at leastone tool to the distractor; inserting the at least one tool in the jointbetween the two bone surfaces of the anatomical structure; and applyinga force to the distractor to force the cutting and/or punch pin into oneof the two bone surfaces.
 13. A distractor system for use in a jointbetween two bone surfaces of an anatomical structure, said distractorsystem comprising: a first pivotable member having a first userengageable arm and an opposite first end; a second pivotable memberhaving a second user engageable arm and an opposite second end, saidfirst pivotable member pivotably connected to said second pivotablemember between said user engageable arms and said ends; a firstconnecting member having a first end and a second end, said first endpivotally connected to said first end of said first pivotable member; asecond connecting member having a first end and a second end, said firstend pivotally connected to said second end of said second pivotablemember; a biasing member for biasing said first arm away from saidsecond arm so that said second end of said first connecting member isbiased towards said second end of said second member; at least onedetachable tool comprising a body having a proximal portion and a distalportion, said proximal portion being releasably attachable to at leastone of said second end of said first connection member and/or saidsecond end of said second connecting member, said distal portion beingoperably positionable in the joint between the two bone surfaces of theanatomical structure; and wherein said distal portion comprises alongitudinal axis and said radiographic marker extends perpendicular tosaid longitudinal axis.
 14. The distractor system of claim 13, whereinsaid distal portion of said at least one detachable tool comprises adetachable paddle.
 15. The distractor system of claim 14, wherein asurface of said distal portion of said detachable paddle comprises araised center portion and a recessed peripheral portion.
 16. Thedistractor system of claim 13, wherein said distal portion of saiddetachable tool comprises at least one cutting and/or punch pin.
 17. Thedistractor system of claim 13, wherein a distal portion of said at leastone detachable tool comprises a detachable resection guide.
 18. Thedistractor system of claim 13, wherein a distal portion of said at leastone detachable tool comprises a detachable implant trialing and cuttingguide.
 19. The distractor system of claim 13, wherein said proximalportion comprise a first longitudinal axis and said distal portioncomprises a second longitudinal axis offset from said first longitudinalaxis.
 20. The distractor system of claim 13, wherein said at least onedetachable tool further comprises a plurality of detachable paddles, adetachable resection guide, and a detachable implant trialing andcutting guide.
 21. The distractor system of claim 13, wherein saidsecond end of said first connecting member comprises a first post, andsaid second end of said second connecting member comprises a secondpost.
 22. The distractor system of claim 21, wherein said first postcomprises a first axis, said second post comprises a second axis, andsaid first axis being maintained parallel to said second axis.
 23. Thedistractor system of claim 21, wherein said second end of said firstconnecting member comprises a first post having a laterally-extendingprojection, and said second end of said second connecting membercomprises a second post having a laterally-extending projection.
 24. Thedistractor system of claim 13, further comprising a ratchet pivotallyattached to said second arm and selectively releasably attachable tosaid first arm, and a scissors mechanism for connecting said firstconnecting member to said second connecting member and operably movablyto maintain said first connecting member parallel to said secondconnecting member.
 25. The distractor system of claim 13, wherein saidat least one detachable tool is sized for being received between twobone surfaces of an ankle joint.
 26. The distractor system of claim 13,wherein said at least one detachable tool is sized for being receivedbetween a tibia and a talus of an ankle joint.
 27. A surgical methodcomprising: providing the distractor system of claim 13; attaching theat least one detachable tool to the distractor; and inserting the atleast one detachable tool in the joint between the bone surfaces of theanatomical structure.
 28. The method of claim 27, further comprisingapplying a compressive force to the arms of the distractor to separatethe two bone surfaces.
 29. A surgical method comprising: providing adistractor system comprising: a first pivotable member having a firstuser engageable arm and an opposite first end; a second pivotable memberhaving a second user engageable arm and an opposite second end, saidfirst pivotable member pivotably connected to said second pivotablemember between said user engageable arms and said ends; a firstconnecting member having a first end and a second end, said first endpivotally connected to said first end of said first pivotable member; asecond connecting member having a first end and a second end, said firstend pivotally connected to said second end of said second pivotablemember; a biasing member for biasing said first arm away from saidsecond arm so that said second end of said first connecting member isbiased towards said second end of said second member; at least onedetachable tool comprising a body having a proximal portion and a distalportion, said proximal portion being releasably attachable to at leastone of said second end of said first connection member and/or saidsecond end of said second connecting member, said distal portion beingoperably positionable in the joint between the two bone surfaces of theanatomical structure; attaching the pair of tools to the distractor;inserting the pair of tools in the joint between the two bone surfacesof the anatomical structure; and applying a compressive force to thearms of the distractor to force a cutting and/or punch pin into one ofthe two bone surfaces.
 30. The surgical method of claim 29, wherein thecutting and/or punch pin comprises longitudinal serrations that extendsa distance greater than a radius of the cutting and/or punch pin. 31.The surgical method of claim 29, wherein the cutting and/or punch pincomprises a plurality of cutting and/or punch pins disposedperpendicular to a longitudinal axis of the distal portion.